Labeling, Promotion, Off-Label Communications, and First Amendment Concerns

July 27, 2017 4:45pm

Scott Danzis
Partner
Covington & Burling LLP (Washington, DC)

Julie Tibbets
Partner
Alston & Bird LLP (Washington, DC)

  • FDA v. FTC regulation
    • Advertising v. labeling
    • Restricted devices, prescription devices, and OTC devices
  • FTC Requirements for Advertising
    • Introduction to FTC Act
    • FTC requirements for substantiation of health claims
    • FTC requirements for endorsements
  • FDA Regulation of Promotion
    • Reviewing FDA’s two recent Guidances on communications related to medical devices
      • “Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities”
      • “Medical Product Communications That Are Consistent With the FDA-Required Labeling”
  • Analyzing FDA’s position on First Amendment
    • Examining FDA’s “Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products”